(72 days)
Not Found
No
The device description and intended use focus on mechanical drainage components and procedures, with no mention of AI or ML capabilities.
Yes
The device is used to relieve symptoms associated with malignant ascites, which directly addresses a health condition.
No.
The device is intended for the drainage of symptomatic malignant ascites, not for the diagnosis of the condition. It is a therapeutic device designed to relieve symptoms.
No
The device description clearly outlines multiple hardware components including a catheter, drainage bag, luer adapter, and valve assembly. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the drainage of fluid from the peritoneal cavity to relieve symptoms. It is a therapeutic device used to manage a condition, not to diagnose or provide information about a patient's health status based on in vitro examination of specimens.
- Device Description: The description focuses on the physical components and their function in draining fluid from the body. It does not mention any components or processes related to analyzing biological samples outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (like blood, urine, tissue, etc.) in vitro, which is the defining characteristic of an IVD.
The device is a therapeutic device used for managing malignant ascites by draining accumulated fluid.
N/A
Intended Use / Indications for Use
The Aspira* Peritoneal Drainage System is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the perioneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
The Aspira* Drainage Bag is indicated for use only with the Aspira* Drainage Catheter for intermittent drainage.
The Aspira* Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira* Luer Adapter is intended to provide access to the Aspira* Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe or other appropriate method.
The Aspira* Valve Assembly attaches to the Aspira* Drainage Catherer. The Aspira* Repair Kit is for the repair of the Aspira* Drainage Catheter and replacement of the Aspira* Valve Assembly.
Product codes
PNG
Device Description
The Aspira* Peritoneal Drainage System is designed for long-term intermittent drainage of recurrent and symptomatic malignant ascites. The Aspira* Peritoneal Drainage System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the system are the Aspira* Periloncal Drainage Catheter and the Aspira* Drainage Bag.
The Aspira* Peritoneal Drainage Catheter is a long-term indwelling silicone catheter used to drain accumulated fluid from the perioncal cavity to relieve symptoms associated with malignant ascites. The fenestrated catheter is placed in the patient's abdominal cavity enabling the patient or caregiver to perform intermittent drainage of their malignant ascites at home.
The Aspira* Drainage Bag is used to collect peritoneal fluid by gravity. The drainage bag attaches to the placed catheter and is activated using an in-line silicone pump.
The Aspira* Luer Adapter is designed to access the Aspira* Drainage Catheter. The lucr adapter is connected to wall suction or a syringe to perform intermittent drainage or catheter maintenance.
The Aspira* Valve assembly attaches to the proximal end of the Aspira* Drainage Catheter to prevent fluid or air exchange through the catheter when not in use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity, abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient or caregiver, at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
C.R. Bard, Inc. Henry Boland Associate Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT 84116
Re: K081288
Trade/Device Name: Aspira* Peritoneal Drainage System Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: PNG Dated: July 1, 2008 Received: July 2, 2008
Dear Henry Boland:
This letter corrects our substantially equivalent letter of July 18, 2008.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
Page 2 - Henry Boland
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Bard Aspira* Peritoncal Drainage System Traditional 510(k)
Section 4 Indications for Use
510(k) Number (if known):
Device Name: Aspira* Peritoneal Drainage System .
Indications for Use:
The Aspira* Peritoneal Drainage System is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the perioneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
The Aspira* Drainage Bag is indicated for use only with the Aspira* Drainage Catheter for intermittent drainage.
The Aspira* Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira* Luer Adapter is intended to provide access to the Aspira* Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe or other appropriate method.
The Aspira* Valve Assembly attaches to the Aspira* Drainage Catherer. The Aspira* Repair Kit is for the repair of the Aspira* Drainage Catheter and replacement of the Aspira* Valve Assembly.
- Aspira is a trademark and/or registered trademark of C. R. Bard, Inc. or an affiliate.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C). (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helmut Romer
vision Sien-C Division of Reproductive. Abdominal. and Radiological Devi
5100k) Number
3
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Bard Aspira* Peritoneal Drainage System Traditional 510(k)
Section 5 510(k) Summary 21 CFR 807.92(a)
JUL 1 8 2008
5.1 General Information
| Submitter Name: | Bard Access Systems, Inc. (BAS) |
|---|---|
| [Wholly owned Subsidiary of C. R. Bard, Inc.] | |
| Address: | 605 North 5600 West |
| Salt Lake City, Utah 84116 | |
| Telephone Number: | (801) 595-0700 ext. 5428 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Henry Boland |
| Date of Preparation: | May 6, 2008 |
| Registration Numbers: | |
| Bard Access Systems: | 3006260740 |
| C. R. Bard: | 2212754 |
5.2 Subject Device Information
| Device Name: | Aspira* Peritoneal Drainage System |
|---|---|
| Trade Name: | Aspira* |
| Common/Usual Name: | Catheter, peritoneal, long-term indwelling |
| Classification Name: | Peritoneal dialysis system and accessories |
| 21 CFR 876.5630, Class II | |
| FJS - Peritoneal dialysis system and accessories | |
| Classification Panel: | Gastroenterology/Urology |
5.3 Predicate Device Information
| Device Name: | Cardinal Health (formerly Denver Biomedical) |
|---|---|
| PLEURX™ Peritoneal Catheter Kit and PLEURX™ | |
| Drainage Kit | |
| Trade Name: | PLEURX™ |
| Common/Usual Name: | Catheter, peritoneal, long-term indwelling |
| Classification Name: | Peritoneal dialysis system and accessories |
| 21 CFR 876.5630 - Class II | |
| FJS - Peritoneal dialysis system and accessories | |
| Classification Panel: | Gastroenterology/Urology |
| 510(k) Clearance: | K051711, concurrence date November 15, 2005 |
5.4 Intended Use
The Aspira* Peritoneal Drainage System is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
5.5 Indications for Usc
4
Image /page/4/Picture/0 description: The image shows the words "Bard Aspira * Peritoneal Drainage System" and the numbers "K081288 262". The text is in black and is on a white background. The text is slightly blurry, but still legible. The numbers are larger than the words.
Traditional 510(k)
The Aspira* Perioneal Drainage System is indicated for internation drainage of recurrent and symptomatic malignant ascites. The catherer is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
The Aspira* Drainage Bag is indicated for use only with the Aspira* Drainage Catheter for intermittent drainage.
The Aspira * Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira* Luer Adapter is intended to provide access to the Aspira* Drainage Catheter. It is used to drain fuid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe or other appropriate method.
The Aspira* Valve Assembly attaches to the Aspira* Drainage Catheter. The Aspira* Repair Kit is for the repair of the Aspira* Drainage Catheter and replacement of the Aspira* Valve Assembly.
Device Description ટ્રીર્દ્
The Aspira* Peritoneal Drainage System is designed for long-term intermittent drainage of recurrent and symptomatic malignant ascites. The Aspira* Peritoneal Drainage System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the system are the Aspira* Periloncal Drainage Catheter and the Aspira* Drainage Bag.
The Aspira* Peritoneal Drainage Catheter is a long-term indwelling silicone catheter used to drain accumulated fluid from the perioncal cavity to relieve symptoms associated with malignant ascites. The fenestrated catheter is placed in the patient's abdominal cavity enabling the patient or caregiver to perform intermittent drainage of their malignant ascites at home.
The Aspira* Drainage Bag is used to collect peritoneal fluid by gravity. The drainage bag attaches to the placed catheter and is activated using an in-line silicone pump.
The Aspira* Luer Adapter is designed to access the Aspira* Drainage Catheter. The lucr adapter is connected to wall suction or a syringe to perform intermittent drainage or catheter maintenance.
The Aspira* Valve assembly attaches to the proximal end of the Aspira* Drainage Catheter to prevent fluid or air exchange through the catheter when not in use.
5.7 Technological Comparison to Predicate Device
The technological characteristics of the Aspira* Peritoneal Drainage System is substantially equivalent to the predicate device, Denver PLEURX™ Peritoneal Catherer Kit and PLEURX™ Drainage Kit, in terms of intended use, application, user population, basic design, performance and labeling.
- Bard and Aspira are trademarks and/or registered trademarks of C. R. Bard, Inc. or an allitine.